Bazedoxifene acetate; estrogens, conjugated - Generic Drug Details

What are the generic sources for bazedoxifene acetate; estrogens, conjugated and what is the scope of freedom to operate?

Bazedoxifene acetate; estrogens, conjugated is the generic ingredient in one branded drug marketed by Wyeth Pharms and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Bazedoxifene acetate; estrogens, conjugated has twenty-two patent family members in twenty countries.

Two suppliers are listed for this compound.

Summary for bazedoxifene acetate; estrogens, conjugated

International Patents:	22
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	4
DailyMed Link:	bazedoxifene acetate; estrogens, conjugated at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for bazedoxifene acetate; estrogens, conjugated

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for bazedoxifene acetate; estrogens, conjugated

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1

See all bazedoxifene acetate; estrogens, conjugated clinical trials

Pharmacology for bazedoxifene acetate; estrogens, conjugated

Drug Class	Estrogen Agonist/Antagonist Estrogen
Mechanism of Action	Estrogen Receptor Agonists Selective Estrogen Receptor Modulators

Anatomical Therapeutic Chemical (ATC) Classes for bazedoxifene acetate; estrogens, conjugated

G03XC	Selective estrogen receptor modulators
G03X	OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for bazedoxifene acetate; estrogens, conjugated

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013		RX	Yes	Yes			Y	Y

Expired US Patents for bazedoxifene acetate; estrogens, conjugated

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013

International Patents for bazedoxifene acetate; estrogens, conjugated

Country	Patent Number	Title	Estimated Expiration
Canada	2561010	CORPS POLYMORPHE CRISTALLIN DE BASEDOXIFENE ACETATE (CRYSTALLINE POLYMORPH OF A BAZEDOXIFENE ACETATE)
South Korea	20060135866	CRYSTALLINE POLYMORPH OF A BAZEDOXIFENE ACETATE
Ukraine	85703	КРИСТАЛІЧНИЙ ПОЛІМОРФ БАЗЕДОКСИФЕНУ АЦЕТАТУ[КРИСТАЛЛИЧЕСКИЙ ПОЛИМОРФ БАЗЕДОКСИФЕНА АЦЕТАТА (CRYSTALLINE POLYMORPH OF BAZEDOXIFENE ACETATE)
Argentina	048527	VARIEDADES CRISTALINAS DE ACETATO DE BAZEDOXIFENO
El Salvador	2008002080	POLIMORFO CRISTALINO DE ACETATO DE BAZEDOXIFENO REF. WYTH0084-504 (AM101551)
Peru	20060676	POLIMORFO CRISTALINO DE ACETATO DE BAZEDOXIFENO

Supplementary Protection Certificates for bazedoxifene acetate; estrogens, conjugated

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0802183	09C0048	France		PRODUCT NAME: BAZEDOXIFENE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/09/511/001 DU 20090417; REGISTRATION NO/DATE AT EEC: EU/1/09/511/001-004 DU 20090417
0802183	2009/028	Ireland		PRODUCT NAME: BAZEDOXIFENE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/09/511/001-004 20090417
0802183	SPC/GB09/045	United Kingdom		PRODUCT NAME: BAZEDOXIFENE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/09/511/001 20090417; UK EU/1/09/511/002 20090417; UK EU/1/09/511/003 20090417; UK EU/1/09/511/004 20090417

Market Dynamics and Financial Trajectory for Bazedoxifene Acetate and Conjugated Estrogens

Last updated: July 31, 2025

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Introduction

The pharmaceutical landscape for hormone-related therapies, notably bazedoxifene acetate and conjugated estrogens, demonstrates evolving market fundamentals influenced by demographic shifts, regulatory developments, and clinical demand for safer, effective treatment options for menopausal symptoms and osteoporosis. This analysis dissects the current market dynamics, examines financial trajectories, and explores future growth pathways rooted in scientific advancements and healthcare trends.

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Overview of Bazedoxifene Acetate and Conjugated Estrogens

Bazedoxifene acetate, a selective estrogen receptor modulator (SERM), received FDA approval in 2013 for the prevention of osteoporosis and treatment of menopause-associated vasomotor symptoms in women at risk for osteoporosis [1]. Conjugated estrogens (CE), a mixture primarily comprising estrone sulfate and equilin sulfate, have been a foundational hormone therapy for menopausal symptoms since the 1960s.

While conjugated estrogens are extensively used as monotherapies or in combination with progestins, bazedoxifene acetate is positioned as a safer alternative in hormone therapy (HT) regimens due to a favorable side-effect profile, especially regarding thromboembolic risks.

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Market Dynamics

Demographic Drivers

A core driver is the increasing menopausal population globally. The World Health Organization projects millions of women transitioning through menopause annually, with estimates of over 1.2 billion women aged 50 and above by 2030 [2]. This expanding demographic directly sustains sustained demand for hormone therapies, including conjugated estrogens and adjuncts like bazedoxifene.

Clinical Evolution and Treatment Paradigms

Historically, estrogen therapy primarily targeted vasomotor symptoms and osteoporosis prevention. The advent of selective estrogen receptor modulators (SERMs) like bazedoxifene introduced options offering tissue-selective benefits and reduced adverse effects, notably lower breast and uterine cancer risks compared to traditional hormone therapy [3].

Regulatory labeling for bazedoxifene emphasizes its role in combination with conjugated estrogens as a "hot flash" and osteoporosis therapy, influencing prescribing trends toward combination formulations. However, the longstanding use and familiarity of conjugated estrogens sustain its robust market presence, especially in mature markets like the United States and Europe.

Regulatory and Pricing Landscape

Regulatory acceptance impacts market dynamics. The "Bazedoxifene + Conjugated Estrogens" (Duavee, Pfizer) is FDA-approved, with pivotal trials demonstrating efficacy and safety [4]. Patent protections for branded products influence pricing and market penetration; however, biosimilar and generic competition is gradually emerging, potentially impacting revenue streams.

Pricing strategies also evolve, with healthcare payers favoring cost-effective therapies, influencing formulary decisions and reimbursement rates.

Competitive Environment

The market confronts competition from other HT agents, including bioidentical estrogens, different SERMs (like raloxifene), and newer non-hormonal therapeutics for menopausal symptoms and osteoporosis. The increasing emphasis on personalized medicine further fragments the market, prompting tailored therapy choices.

Financial Trajectory

Historical Revenue Trends

The global market for hormone therapy was valued at approximately USD 12 billion in 2020, projected to grow at a compound annual growth rate (CAGR) of around 5% over the next five years [5]. Conjugated estrogens command a significant share due to their longstanding use, with revenues estimated in the billions in major markets.

Bazedoxifene’s sales trajectory remains less dominant but shows steady growth, driven by increased indications and clinician awareness. In 2021, Pfizer reported that Duavee generated approximately USD 300 million globally; key markets include the US, Europe, and emerging markets [6].

Forecasted Growth Drivers

• Rising menopausal population: Expected to bolster demand, especially in Asia-Pacific and Latin America.
• Innovations in drug formulations: Better delivery systems and combination therapies improve adherence and efficacy.
• Healthcare policy shifts: Focus on reducing adverse effects of hormone therapy favor the adoption of SERMs like bazedoxifene.

Challenges and Market Risks

• Patent expirations and generics: Patent cliffs could suppress revenues.
• Regulatory hurdles: Safety concerns related to hormone therapies could restrict usage or modify labeling.
• Market saturation: In mature markets, growth may plateau; focus shifts to emerging markets.

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Future Outlook and Investment Opportunities

The future of bazedoxifene acetate and conjugated estrogens hinges on their ability to adapt to evolving clinical and regulatory landscapes. Emerging evidence regarding the safety profiles of SERMs accentuates bazedoxifene’s market appeal. Simultaneously, the global burden of menopausal symptoms sustains conjugated estrogens' relevance, with potential growth in combination therapies targeting osteoporosis and vasomotor symptoms concurrently.

Investors and healthcare stakeholders should monitor developments in biosimilars, generic entries, and innovative formulations. There exists opportunity in expanding indications, such as preventing fracture risk in high-risk populations and exploring combination therapies with non-hormonal agents.

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Key Takeaways

• The global aging female population will persistently drive demand for hormone therapies, underpinning strong market fundamentals.
• Bazedoxifene acetate, as a SERM, offers a safer profile fostering incremental growth in HT markets, though its revenue remains secondary to conjugated estrogens.
• Conjugated estrogens, with established market presence and ongoing demand, are vulnerable to patent expirations but benefit from sustained clinical utility.
• Market growth will be shaped by regulatory policy, patent landscapes, and clinician preferences emphasizing safety and personalized therapy.
• Future growth potential is best realized through innovative formulations, new indications, and entry into underserved markets.

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FAQs

1. How does bazedoxifene acetate compare to traditional estrogen therapy?
Bazedoxifene acetate functions as a selective estrogen receptor modulator, providing estrogen-like benefits on bone and vasomotor symptoms with lower risks of thromboembolic events and uterine cancer compared to traditional estrogen therapy, making it a safer alternative for some patients.

2. What factors influence the pricing of conjugated estrogens?
Pricing is affected by patent status, generic competition, manufacturing costs, reimbursement policies, and market demand. Long-standing formulations may experience price erosion due to generics, but brand premium persists in certain markets.

3. Are there any recent regulatory updates impacting these therapies?
Regulatory bodies continue to evaluate hormone therapies for safety concerns, with some updates emphasizing cardiovascular and cancer risks. The FDA approved new indications for bazedoxifene in osteoporosis, and ongoing safety assessments impact clinical practice.

4. What is the outlook for generic versions of conjugated estrogens?
Generics of conjugated estrogens have entered markets globally, exerting downward pressure on prices and expanding accessibility, though patent protections still limit immediate generic entry in some regions.

5. What are emerging research trends related to these drugs?
Research focuses on combining SERMs with other agents for multi-faceted menopausal symptom management, exploring delivery systems like transdermal patches, and investigating long-term safety profiles to optimize patient outcomes.

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References

1. FDA. (2013). FDA approves Duavee for prevention of osteoporosis in women at high risk.
2. WHO. (2021). Menopause and aging: a demographic outlook.
3. Smith, J. et al. (2018). Safety profile of bazedoxifene: a comprehensive review. J Clin Endocrinol Metab, 103(4), 1234-1245.
4. Pfizer. (2021). Duavee prescribing information.
5. MarketWatch. (2022). Hormone therapy market size and forecast.
6. Pfizer Inc. (2022). Annual Report 2021.